NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Linda Powers, March 2023:

Linda Powers, CEO of NW Bio, commented “We are very excited to reach this major milestone (commercial manufacturing facility licensed), as it is an essential step towards submission of our application for regulatory approval of our lead product, DCVax®-L. It is especially exciting to be able to operate globally from this base in the U.K.”

2023 10k

The manufacturing process today is also rapid: about eight days for DCVax-L, and seven days for DCVax-Direct, followed by quality control and release testing (including a sterility test that may take a couple of weeks).

As previously reported, we have been developing a manufacturing facility in Sawston, U.K. The Sawston facility contains a total of 88,345 square feet on two floors. The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have anticipated potential capacity to produce dendritic cell (DCVax-l) vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually. (Additionally) The buildout of Phases 1A and 1B of the facility have been completed. We also continue to conduct production activities in the GMP (clean room) facility in London.

On March 20, 2023, a MIA license was approved by the MHRA for commercial manufacturing of cell therapy products at the GMP facility in Sawston, U.K. A license from the Human Tissue Authority (HTA) for collection and handling of tumor tissue and immune cells had previously been obtained in October 2021, and a license for manufacturing products for clinical trials and compassionate use in the Sawston facility was approved by MHRA in December 2021.